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Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

2017年8月25日 更新者：Celgene

A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

488

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Massachusetts General Hospital
    • Texas
      • Houston、Texas、アメリカ、77030
        • MD Anderson Cancer Center
  • イギリス
      • Bournemouth、イギリス、BH7 7DW
        • Royal Bournemouth Hospital
      • London、イギリス、SE5 9RS
        • King's College Hospital
      • London、イギリス、EC1A 7BE
        • Barts and the London NHS Trust
      • Manchester、イギリス、M13 9WL
        • Manchester Royal Infirmary
      • Oxford、イギリス、OX3 9DS
        • Churchill Hospital
      • Wolverhampton、イギリス、WV10 0QP
        • New Cross Hospital
    • Surrey
      • Sutton、Surrey、イギリス、SM2 5PT
        • Royal Marsden Hospital
  • イスラエル
      • Beer Yaakov、イスラエル、70300
        • Assaf Harofeh Medical Centre
      • Jerusalem、イスラエル、91120
        • Hadassah Medical Center
      • Jerusalem、イスラエル、91031
        • Shaare Zedek Medical Center
      • Petach Tikva、イスラエル、49100
        • Rabin Medical Center
      • Tel Aviv、イスラエル、64239
        • Sourasky Medical Center
      • Tel Hashomer、イスラエル、52621
        • Chaim Sheba Medical Center - Tel Hashomer, Heart Institute
    • Beersheva
      • Beer Sheva、Beersheva、イスラエル、84101
        • Soroka Medical Center
  • イタリア
      • Alessandria、イタリア、15121
        • Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
      • Ancona、イタリア、60126
        • Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona
      • Bari、イタリア、70124
        • Azienda Ospedaliera Policlinico Di Bari
      • Bologna、イタリア、40138
        • Azienda Ospedaliera Sant'Orsola Malpighi
      • Firenze、イタリア、50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Reggio Calabria、イタリア、89100
        • Azienda Ospedaliera Bianchi-Melacrino-Morelli
      • Roma、イタリア、00168
        • Policlinico Universitario Agostino Gemelli
      • Roma、イタリア、00161
        • Azienda Policlinico Umberto I di Roma
      • Udine、イタリア、33100
        • Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
      • Varese、イタリア、21100
        • Ospedale di Circolo e Fondazione Macchi
    • Potenza
      • Rionero in Vulture、Potenza、イタリア、85028
        • IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
    • Turin
      • Orbassano、Turin、イタリア、10043
        • Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"
  • オランダ
      • Groningen、オランダ、9700 RB
        • Universitair Medisch Centrum Groningen
  • オーストラリア
      • Fitzroy、オーストラリア、3065
        • St Vincent's Hospital
    • New South Wales
      • Randwick、New South Wales、オーストラリア、2031
        • Prince of Wales Hospital
    • South Australia
      • Adelaide、South Australia、オーストラリア、5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne、Victoria、オーストラリア、3002
        • Peter MacCallum Cancer Centre
      • Footscray、Victoria、オーストラリア、3011
        • Western Hospital
      • Melbourne、Victoria、オーストラリア、3050
        • Royal Melbourne Hospital
  • オーストリア
      • Salzburg、オーストリア、5020
        • Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung
    • Upper Austria
      • Wels、Upper Austria、オーストリア、4600
        • Klinikum Wels-Grieskirchen GmbH
    • Vienna
      • Wien、Vienna、オーストリア、1160
        • Wilhelminenspital, I Medizinische Abt.
  • カナダ
      • Calgary、カナダ、T2N 2T9
        • Tom Baker Cancer Centre
      • Ontario、カナダ、M5G 2M9
        • Princess Margaret Hospital
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 2B7
        • University of Alberta Hospital
    • Manitoba
      • Winnipeg、Manitoba、カナダ、R3E 0V9
        • Cancer Care Manitoba
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 2Y9
        • Queen Elizabeth Ii Health Sciences Centre
    • Ontario
      • Ottawa、Ontario、カナダ、K1H8L6
        • Ottawa Hospital General Campus
      • Toronto、Ontario、カナダ、M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal、Quebec、カナダ、H1T 2M4
        • Hopital Maisonneuve-Rosemont
      • Montreal、Quebec、カナダ、H4J 1C5
        • Hopital Du Sacre Coeur de Montreal
      • Montreal、Quebec、カナダ、H2L 4M1
        • Centre Hospitalier de l'Université de Montréal pavilion Notre Dame
  • スペイン
      • Barcelona、スペイン、08036
        • Hospital Clinic i Provincial de Barcelona
      • Madrid、スペイン、28009
        • Hospital General Universitario Gregorio Marañón
      • Salamanca、スペイン、37007
        • Hospital Universitario De Salamanca
      • Sevilla、スペイン、41013
        • Hospital Universitario Virgen del Rocío
      • Valencia、スペイン、46009
        • Hospital Universitario La Fe
    • Asturias
      • Oviedo、Asturias、スペイン、33006
        • Hospital Central de Asturias
    • Baleares
      • Palma de Mallorca、Baleares、スペイン、07198
        • Hospital Son Llatzer
      • Palma de Mallorca、Baleares、スペイン、07014
        • Hospital Son Dureta
  • チェコ
    • Jihormoravsky Kraj
      • Brno、Jihormoravsky Kraj、チェコ、625 00
        • Fakultni nemocnice Brno
    • Olomoucký Kraj
      • Olomouc、Olomoucký Kraj、チェコ、775 20
        • Fakultni nemocnice Olomouc, Hemato-onkologicka klinika
    • Praha
      • Praha 2、Praha、チェコ、128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 2、Praha、チェコ、128 20
        • Ustav hematologie a krevni transfuze
  • ドイツ
    • Baden-wuerttemberg
      • Heidelberg、Baden-wuerttemberg、ドイツ、69120
        • Universitatsklinikum Heidelberg
      • Ulm、Baden-wuerttemberg、ドイツ、89081
        • Universitätsklinikum Ulm
    • Mecklenburg-vorpommern
      • Rostock、Mecklenburg-vorpommern、ドイツ、18057
        • University of Rostock, Div. of Haematology and Oncology
    • Nordrhein-Westfallen
      • Essen、Nordrhein-Westfallen、ドイツ、45122
        • Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie
    • Nordrhein-westfalen
      • Düesseldorf、Nordrhein-westfalen、ドイツ、40211
        • Heinrich-Heine-Universität Düsseldorf
    • Sachsen
      • Leipzig、Sachsen、ドイツ、04103
        • Universitatsklinikum Leipzig
    • Thueringen
      • Jena、Thueringen、ドイツ、07747
        • Universitatsklinikum Jena
  • フランス
      • Aquitaine、フランス、64109
        • Centre Hospitalier de la Côte Basque
      • Lyon Cedex 03、フランス、69437
        • Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot
    • Alsace
      • Strasbourg、Alsace、フランス、67091
        • Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre
    • ILE-DE-France
      • Bobigny、ILE-DE-France、フランス、93009
        • Hospital Avicenne, Service d'hematologie Clinique
    • Ile-de-france
      • Clamart Cedex、Ile-de-france、フランス、92141
        • Hopital Percy Clamart
      • Paris Cedex 10、Ile-de-france、フランス、75475
        • Hopital Saint Louis
    • Limousin Lorraine
      • Limoges、Limousin Lorraine、フランス、87042
        • Centre Hopitalier Universitaire Dupuytren
    • Midi-pyrénées
      • Toulouse Cedex 09、Midi-pyrénées、フランス、31059
        • Centre Hospitalier Universitaire de Toulouse
    • Nice
      • Nice Cedex 3、Nice、フランス、06202
        • Centre Hospitalier Universitaire De Nice
    • Pays de La Loire
      • Angers cedex 09、Pays de La Loire、フランス、49933
        • CHRU d'Angers
      • Nantes Cedex 1、Pays de La Loire、フランス、44093
        • Centre Hospitalier Universitaire Nantes, Hotel Dieu
    • Picardie
      • Amiens Cedex 1、Picardie、フランス、80054
        • Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud
    • Provence Alpes Cote D'azur
      • Marseille、Provence Alpes Cote D'azur、フランス、13385
        • Hopital de la Conception
  • ベルギー
      • La Louvière、ベルギー、7100
        • Centre Hospitalier de Jolimont-Lobbes
    • Hainaut
      • Charleroi、Hainaut、ベルギー、6000
        • Grand Hôpital de Charleroi
    • Namur
      • Yvoir、Namur、ベルギー、5530
        • Cliniques Universitaires UCL de Mont-Godinne
    • Oost-vlaanderen
      • Ghent、Oost-vlaanderen、ベルギー、9000
        • Universitair Ziekenhuis Gent
    • West-vlaanderen
      • Brugge、West-vlaanderen、ベルギー、8000
        • Algemeen Ziekenhuis Sint-Jan
  • ポーランド
    • Dolnoslaskie
      • Wroclaw、Dolnoslaskie、ポーランド、50-367
        • Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
      • Wroclaw、Dolnoslaskie、ポーランド、53-439
        • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
    • Lodzkie
      • Lódz、Lodzkie、ポーランド、93-510
        • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
    • Mazowieckie
      • Warszawa、Mazowieckie、ポーランド、02-776
        • Instytut Hematologii i Transfuzjologii
    • Slaskie
      • Katowice、Slaskie、ポーランド、40-032
        • Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
  • ロシア連邦
      • Ekaterinburg、ロシア連邦、620137
        • Central city hospital # 7
      • Moscow、ロシア連邦、125284
        • City Clinical Hospital n.a. S. P. Botkin
      • Nizhniy Novgorod、ロシア連邦、603126
        • State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"
      • Saint Petersburg、ロシア連邦、197089
        • Saint Petersburg State Academician I.P. Pavlov Medical University
      • Saratov、ロシア連邦、410 028
        • Saratov State Medical University
  • 中国
      • Beijing、中国、100730
        • Peking Union Medical College Hospital
      • Beijing、中国、100083
        • The Third Hospital of Peking University
      • Jiangsu、中国、210029
        • Peoples Hospital of Jiangsu Province
      • Shanghai、中国、200025
        • Shanghai Ruijin Hospital
      • Shanghai、中国、200433
        • Shanghai Changhai Hospital,the Second Military Medical University
      • Sichuan、中国、610041
        • West China Hospital,Sichuan University
      • Tianjin、中国、3000200
        • Tianjin Blood Disease Hospital
  • 台湾
      • Taipei、台湾、10002
        • National Taiwan University Hospital
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital Pei-Tou District
    • Kaohsiung
      • Niao-Sung Hsiang、Kaohsiung、台湾、83301
        • Chang Gung Memorial Hospital, Kaohsiung
  • 大韓民国
      • Daegu、大韓民国、700-721
        • Kyungpook National University Hospital
      • Seoul、大韓民国、138-736
        • Asan Medical Center
      • Seoul、大韓民国、152-703
        • Korea University Hospital at Guro
      • Seoul、大韓民国、137-701
        • Seoul Saint Mary's Hospital Seocho-gu
    • Seoul
      • Gangnam-gu、Seoul、大韓民国、135-710
        • Samsung Medical Center
      • Jongno-gu、Seoul、大韓民国、110-774
        • Seoul National University Hospital
      • Seodaemun-gu、Seoul、大韓民国、120-752
        • Yonsei University Health System

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Diagnosis of one of the following

    • Newly diagnosed de novo acute myeloid leukemia (AML)
    • AML secondary to myelodysplastic syndromes (MDS)
    • AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
  • Bone marrow blasts >30%
  • Age ≥ 65 years
  • Easter Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

  • Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
  • Previous treatment with azacitidine, decitabine or cytarabine
  • Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
  • AML French American British subtype (FAB M3)
  • AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
  • Prior bone marrow or stem cell transplantation
  • Candidate for allogeneic bone marrow or stem cell transplant
  • Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
  • Malignant hepatic tumors
  • Uncontrolled systemic infection
  • Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
  • Use of any experimental drug or therapy within 28 days prior to Day 1

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Azacitidine
Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
薬：Azacitidine
75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
他の名前：
  • ヴィダーザ
アクティブコンパレータ：Conventional Care Regimen
薬：Conventional Care Regimen

Physician pre-selects prior to randomization from one of the following:

  • Intensive chemotherapy (cytarabine 100-200 mg/m^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
  • Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
  • Best Supportive Care only; until study end

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Kaplan-Meier Estimates for Overall Survival
時間枠：Day 1 (randomization) to 40 months
Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.
Day 1 (randomization) to 40 months

二次結果の測定

結果測定
メジャーの説明
時間枠
One-year Overall Survival Rate
時間枠：From Day 1 (randomization) to 40 months
Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.
From Day 1 (randomization) to 40 months
Event-free Survival (EFS)
時間枠：Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months
Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.
Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months
Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
時間枠：Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months
Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.
Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months
Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)
時間枠：Day 1 (randomization) to 40 months
A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.
Day 1 (randomization) to 40 months
Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates
時間枠：Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.
Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.
Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.
時間枠：Day 1 (randomization) to 40 months
The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment
Day 1 (randomization) to 40 months
Number of Participants With Adverse Events (AEs)
時間枠：Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
時間枠：Baseline to Cycle 3; at approximately 3 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 3; at approximately 3 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
時間枠：Baseline to Cycle 5, at approximately 5 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 5, at approximately 5 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
時間枠：Baseline to Cycle 7, at approximately 7 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 7, at approximately 7 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
時間枠：Baseline to Cycle 9, at approximately 9 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to Cycle 9, at approximately 9 months
Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain
時間枠：Baseline to End of Study; at approximately 11-12 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).
Baseline to End of Study; at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
時間枠：Baseline to Cycle 3, at approximately 3 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
時間枠：Baseline to Cycle 5, at approximately 5 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
時間枠：Baseline to Cycle 7, at approximately 7 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
時間枠：Baseline to Cycle 9, at approximately 9 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea
時間枠：Baseline to end of study, at approximately 11-12 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).
Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
時間枠：Baseline to Cycle 3, at approximately 3 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
時間枠：Baseline to Cycle 5, at approximately 5 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
時間枠：Baseline to Cycle 7, at approximately 7 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
時間枠：Baseline to Cycle 9, at approximately 9 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
時間枠：Baseline to end of study, at approximately 11-12 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Baseline to end of study, at approximately 11-12 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
時間枠：Baseline to Cycle 3, at approximately 3 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 3, at approximately 3 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
時間枠：Baseline to Cycle 5, at approximately 5 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 5, at approximately 5 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
時間枠：Baseline to Cycle 7, at approximately 7 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 7, at approximately 7 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
時間枠：Baseline to Cycle 9, at approximately 9 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to Cycle 9, at approximately 9 months
HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain
時間枠：Baseline to end of study, at approximately 11-12 months
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.
Baseline to end of study, at approximately 11-12 months
Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations
時間枠：Day 1 (randomization) to 40 months
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Day 1 (randomization) to 40 months
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
時間枠：Day 1 (randomization) to 40 months
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Day 1 (randomization) to 40 months
HRU: Number of Participants Receiving Transfusions
時間枠：Day 1 (randomization) to 40 months
Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
Day 1 (randomization) to 40 months
HRU: Rate of Transfusions Per Patient Year
時間枠：Day 1 (randomization) to 40 months
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Day 1 (randomization) to 40 months
Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)
時間枠：From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days
AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Celgene

捜査官

  • スタディディレクター：C L Beach, PharmD、Celgene Corporation

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2010年6月1日

一次修了 (実際)

2014年1月22日

研究の完了 (実際)

2016年7月25日

試験登録日

最初に提出

2010年2月16日

QC基準を満たした最初の提出物

2010年2月22日

最初の投稿 (見積もり)

2010年2月24日

学習記録の更新

投稿された最後の更新 (実際)

2017年8月29日

QC基準を満たした最後の更新が送信されました

2017年8月25日

最終確認日

2017年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AZA-AML-001

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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